Microsatellite InstabilityNCT03744962
MSI in Circulatory DNA of Endometrial Cancer
An observational study of Microsatellite Instability and Lynch Syndrome, run by Lei Li at 1 site in China.
Trial summary
This study aims to analyze the microsatellite instability (MSI) in the circulatory tumor DNA and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. These data will be used for the study of "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer"… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Microsatellite Instability, Lynch Syndrome, Endometrial Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 23 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients confirmed primary endometrial cancer before any surgical or chemotherapy treatment will be all included.
Who may be able to join
- Confirmed primary endometrial cancer before any surgical or chemotherapy treatment
- Signed an approved informed consents
- Feasible for sampling
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 13911988831 ext. 86, lileigh@163.com
About this study
Official title: A Compare of Microsatellite Instability in Circulatory DNA and Tumor Tissue of Endometrial Cancer
This study aims to analyze the microsatellite instability (MSI) in the circulatory tumor DNA and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. These data will be used for the study of "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov).
- Medical subject headings
- Microsatellite Instability, Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms, Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of microsatellite instability
Frequencies of different status of microsatellite instability (high microsatellite instability or microsatellite-stable) in the circulatory tumor DNA and in the tumor tissue
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start10 Nov 2018
- Primary completion23 Dec 2020 (estimated)
- Study completion23 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsatellite InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744962
- Sponsor's protocol ID
- EC-MSI
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Compare of Microsatellite Instability in Circulatory DNA and Tumor Tissue of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03744962
- Acronym / sponsor ID
- EC-MSI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 23 Dec 2020 (estimated)
- Study completion
- 23 Dec 2020 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to analyze the microsatellite instability (MSI) in the circulatory tumor DNA and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. These data will be used for the study of "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients confirmed primary endometrial cancer before any surgical or chemotherapy treatment will be all included.
Key inclusion criteria (3 listed)
- Confirmed primary endometrial cancer before any surgical or chemotherapy treatment
- Signed an approved informed consents
- Feasible for sampling
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of microsatellite instability
Time frame: Two years
Frequencies of different status of microsatellite instability (high microsatellite instability or microsatellite-stable) in the circulatory tumor DNA and in the tumor tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microsatellite Instability and Lynch Syndrome, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (13911988831 ext. 86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of microsatellite instability (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.